The efficacy and safety of omalizumab in the treatment of asthma: an overview of systematic reviews and meta analyses

Abstract

Introduction: Omalizumab, an anti-IgE monoclonal antibody, is an established biologic for asthma. This overview synthesized evidence from systematic reviews on its efficacy and safety. Methods: We systematically searched multiple electronic databases from inception to July 19, 2025. The methodological quality, risk of bias, reporting quality, and certainty of evidence of the included systematic reviews were assessed using the AMSTAR-2, ROBIS, PRISMA 2020, and GRADE tools, respectively. The degree of overlap among primary studies across reviews was measured using the Corrected Covered Area (CCA). Results: Nineteen studies were included. The CCA calculation indicated a moderate level of overlap (CCA ≈ 0.1421). Most demonstrated low risk of bias, high methodological/reporting quality, and provided moderate-to-high certainty evidence. Omalizumab significantly reduced asthma exacerbation rates and improved overall treatment effectiveness, asthma control, and quality of life. It also facilitated a reduction in daily corticosteroid use, with a confirmed favorable safety profile. Conclusion: This overview confirms that omalizumab is an effective and safe add-on therapy for asthma. Its mechanism of neutralizing free IgE translates into significant clinical benefits, including reduced exacerbations and improved patient outcomes, establishing it as a valuable therapeutic option. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/, CRD420251107860.